Abstract
This second of three consecutive chapters that discusses subgroup analyses covers the rules that govern subgroup analyses interpretation. A distinction is drawn between a subgroup analysis that compares the effect of a randomly allocated intervention in a clinical trial across subgroup strata on the one hand, and the analysis which only seeks to confirm the efficacy of therapy within a single subgroup stratum on the other. Finally three controversial uses of subgroup analyses are provided.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Yusuf, S, Wittes J., Probstfield, J., Tyroler, H.A. (1991). Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. Journal of the American Medical Associatio 266:93–8.
Peterson, B., George, S.L. (1993). Sample size requirements and length of study for testing interaction in a 1×k factorial design when time-to-failure is the outcome. Controlled Clinical Trials 14:511–522.
Horwitz, R.I., Singer, B., Makuch, R.W., Viscoli, C.M. (1996). Can treatment that is helpful on average be harmful to some patients? A study of the conflicting information needs of clinical inquiry and drug regulation. Journal of Clinical Epidemiology 49:395–400.
Altman, D.G. (1998). Within trial variation — A false trial? Journal of Clinical Epidemiology 51:301–303.
Feinstein, A.R. (1998). The problem of cogent subgroups: A clinicostatistical tragedy. Journal of Clinical Epidemiology 51:297–299.
Lee, K.L., McNeer, F., Starmer, C.F., Harris, P.J., Rosari, R.A. (1980). Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease. Circulation 61:508–15.
Simon, R. (1982). Patient subsets and variation in therapeutic efficacy. British Journal of Clinical Pharmacology 14:473–482.
Pocock, S.J. (1983). Clinical Trials; A Practical Approach; Chichester. John Wiley & Sons. p213–215.
Friedman, L., Furberg, C., and DeMets, D. (1996). Fundamentals of Clinical Trials 3rd ed. New York. Springer.
Meinert, C.L. (1986). Clinical Trials Design, Conduct, and Analysis. New York: Oxford University Press.
The International Steering Committee on behalf of the MERIT-HF Study Group (1997). Rationale, design, and organization of the metoprolol CR/XL randomized trial in heart failure (MERIT-HF). American Journal of Cardiology 80:54–58.
MERIT-F Study Group. (1999). Effect of metoprolol cr/xl in chronic heart failure. Metoprolol cr/xl randomized intervention trial in congestive heart failure (MERIT-HF) Lancet 353:2001–2007.
Califf, R.M., O’Connor, C.M. (2000). β-blocker therapy for heart failure; the evidence is in, now the work begins. Journal of the American Medical Association 283:1335–1336.
Carson, P., Ziesche, S., Johnson, G., Cohn, J.N. (1999). Racial differences in response to therapy for heart failure; analysis of the vasodilator-heart failure trials. Journal of Cardiac Failure 5:357–382.
The SOLVD Investigators. Effect of enalapril on mortality and the development of heart filure in aymptomatic patients with reduced left ventricular ejection fraction. New England Journal of Medicine. 327:685–91. [Erratum, New England Journal of Medicine 327:1768.
The SOLVD Investigators. (1991). Effect of enalapril on survival in patients with reduced left ventricular ejection fraction and congestive heart failure. New England Journal of Medicine 325:293–302.
Dries, D.L., Exner, D.V., Gersh, B.J., Cooper, H.A., Carson, P.E., Domanski, M.J. (1999). Racial differences in the outcome of left ventricular dysfunction. New England Journal of Medicine 340:609–616.
Swartz, R.S. (2001). Racial profiling in medical research. New England Journal of Medicine 344:1392–1393.
Wood, A.J. (2001). Racial differences in the response to drugs — pointers to genetic differences. New England Journal of Medicine 344.1393–1395
MRFIT Investigators. (1982). Multiple risk factor intervention trial Journal of the American Medical Association 248:1465–1477.
National Emphysema Treatment Trial Research Group (2001) Patients at high-risk of death after lung-volume-reduction surgery. New England Journal of Medicine 345:1075–1083.
Editorial: Now for the real cancer vaccines. The Wall Street Journal. November 26, 2002.
Rights and permissions
Copyright information
© 2003 Springer-Verlag New York, Inc.
About this chapter
Cite this chapter
(2003). Subgroups II: Effect Domination and Controversy. In: Multiple Analyses in Clinical Trials. Statistics for Biology and Health. Springer, New York, NY. https://doi.org/10.1007/0-387-21813-0_11
Download citation
DOI: https://doi.org/10.1007/0-387-21813-0_11
Publisher Name: Springer, New York, NY
Print ISBN: 978-0-387-00727-4
Online ISBN: 978-0-387-21813-7
eBook Packages: Springer Book Archive